Carmustine 100 mg powder and solvent for concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carmustine

Available from:

Tillomed Pharma GmbH

ATC code:

L01AD; L01AD01

INN (International Name):

Carmustine

Dosage:

100 milligram(s)

Pharmaceutical form:

Powder and solvent for concentrate for solution for infusion

Therapeutic area:

Nitrosoureas; carmustine

Authorization status:

Marketed

Authorization date:

2020-01-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CARMUSTINE 100 MG POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
carmustine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Carmustine is and what it is used for
2.
What you need to know before you use Carmustine
3.
How to use Carmustine
4.
Possible side effects
5.
How to store Carmustine
6.
Contents of the pack and other information
1.
WHAT CARMUSTINE IS AND WHAT IT IS USED FOR
Carmustine 100 mg powder and solvent for concentrate for solution for
infusion is a medicine which
contains carmustine. Carmustine belongs to a group of anticancer
substances known as nitrosourea that
act by slowing the growth of cancer cells.
Carmustine is used as palliative therapy (relieving and preventing the
suffering of patients) as a single
agent or in established combination therapy with other approved
anticancer substances in certain types
of cancers, like:
•
Brain tumours; glioblastoma, medulloblastoma, astrocytoma and
metastatic brain tumours
•
Multiple myeloma (malignant tumour developing from bone marrow)
•
Hodgkin’s disease (lymphoid tumour)
•
Non-Hodgkin’s lymphomas (lymphoid tumour)
•
Tumours of gastrointestinal tract or digestive system tract
•
Malignant melanoma (skin cancer)
Carmustine is also used as a conditioning therapy before
transplantation of your own blood stem cells
(autologous stem cell transplantation) in malignant hematological
diseases of the lymphatic system
(Hodgkin’s lymphoma and non-Hodgkins lymphoma).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CARMUSTINE
DO NOT USE CARMUSTINE
-
if you are allergic to carmustine or any of the other ingredients of
this medicine (

Summary of Product characteristics

Health Products Regulatory Authority
20 October 2023
CRN00DX34
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carmustine 100 mg powder and solvent for concentrate for solution for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder for concentrate for solution for infusion contains
100 mg carmustine.
After reconstitution (see section 6.6), one mL of solution contains
33.3 mg carmustine.
Excipient with known effect
Each vial of solvent contains 3 mL propylene glycol (equivalent to
3.1125 g).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for concentrate for solution for infusion.
Powder: Pale yellow powder with small quantities of dried flakes or as
a dry rigid mass.
Solvent: Clear, colourless, viscous liquid.
The pH and osmolarity of ready-to-use solutions for infusion are:
pH: 4.0 to 6.8 whether diluted with physiological saline or with 5 %
dextrose solution
Osmolarity: 320 to 390 mOsmol/l (if diluted in dextrose 50 mg/mL [5 %]
solution for injection) or in sodium chloride 9 mg/mL
[0.9 %] solution for injection)
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carmustine is indicated as palliative therapy as a single agent or in
established combination therapy with other approved
chemotherapeutic agents in the following:

Brain tumours - glioblastoma, medulloblastoma, astrocytoma and
metastatic brain tumours.

Multiple myeloma - in combination with glucocorticoid such as
prednisone.

Hodgkin's disease - as secondary therapy in combination with other
approved drugs in patients who relapse while
being treated with primary therapy, or who fail to respond to primary
therapy.

Non-Hodgkin's lymphomas - as secondary therapy in combination with
other approved drugs in patients who
relapse while being treated with primary therapy, or who fail to
respond to primary therapy.

Tumours of the GI tract

Malignant melanoma when used in combination with other antineoplastic
drugs.

Conditioning prior to autol